There are numerous supporting publications showing that various molecules of the inflammatory cascade lead to initiation and progression of preterm labor123. Currently, studies focusing on altering the immune system in pregnancy all aim to alter the immune system in the whole body of the mother; this not only dilutes the potency of the approach, but also exposes the mother to possible off-target toxicities. By implanting a device that alters selectively the immunological microenvironment at the maternal-fetal interface, the company expects to achieve superior results to previous approaches.

"This is the third patent that we filed based on intellectual property purchased from OmniBiome Therapeutics Inc. We are excited about the strategic approach of the late founder of OmniBiome, David Palella, whose team attacked the problem of pregnancy complications in a multi-level and multi-disciplinary manner," said Timothy Dixon, CEO of Therapeutic Solutions International, Inc.

According to the Centers for Disease Control and Prevention, in 2012, preterm birth affected more than 450,000 babies -- that's 1 of every 9 infants born in the United States. Preterm birth is the birth of an infant before 37 weeks of pregnancy. Preterm-related causes of death together accounted for 35% of all infant deaths in 2010, more than any other single cause. Preterm birth is also a leading cause of long-term neurological disabilities in children. Preterm birth costs the U.S. health care system more than $26 billion in 20054.

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